Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"

Takeda

Status: Completed

Conditions: Impaired Glucose Tolerance

Treatments: Drug: Voglibose

Study type: Observational

Funder types: Industry

Identifiers

NCT01993927

340-012

JapicCTI-132304 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.

Full description

This is a special drug use surveillance on long-term use of Voglibose (Basen) designed to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.

Particioants will be patients with impaired glucose tolerance. The planned sample size is 1,000.

The usual adult dosage is 0.2 mg of voglibose administered orally three times daily immediately before each meal.

Enrollment: 742 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must meet all of the following criteria ([1] to [3]) to be included in this study:

  1. Determined as having IGT (defined as fasting blood glucose < 126 mg/dL and 2-hour post 75-g oral glucose tolerance test [OGTT] blood glucose of 140-199 mg/dL) without improvement despite treatment with diet therapy and exercise therapy for 3-6 months

  2. Meets any of the following conditions:

     (i) Concurrently has hypertension*1 (ii) Concurrently has dyslipidemia*2 (iii) Is obese (BMI ≥25 kg/m^2) (iv) Has a family history of diabetes mellitus in relatives to the second degree as defined by Japanese law*3

  3. Regularly visits the study site and can be observed for 72 weeks

     • 1: Hypertension: Patients with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, or patients on oral antihypertensive medication.
     • 2: Dyslipidaemia: Participants with any of the following conditions or participants on oral antidyslipidemic medication

• Hyper LDL cholesterolemia (fasting LDL-cholesterol ≥140 mg/dL)

• Hypo HDL cholesterolemia (fasting HDL-cholesterol < 40 mg/dL)

• Hypertriglyceridemia (fasting triglyceride ≥150 mg/dL) *3: Relatives to the second degree of consanguinity refer to blood relatives who are the subject's "father or mother, grandfather or grandmother, brothers or sisters, children, or grandchildren." Note that these do not include spouse's relatives.

Exclusion criteria

• Participants meeting either of the following criteria ([1] or [2]) will be excluded:

  1. Previously diagnosed with diabetes mellitus

  2. Has any contraindications to Basen as specified below:

     (i) Severe ketosis, diabetic coma or precoma (ii) Severe infection, perioperative state, or serious trauma (iii) History of hypersensitivity to any ingredients of Basen

Trial design

742 participants in 1 patient group

Voglibose 0.2 mg or OD Tablets 0.2 mg

Description:

Voglibose 0.2 mg or OD Tablets 0.2 mg will be administered orally three times daily immediately before each meal.

Treatment:

Drug: Voglibose